This Phase II, randomized, open-label, international, multicenter trial is designed to evaluate the safety and efficacy of rituximab monotherapy when given according to a dose intense regimen and to assess the safety, efficacy, and pharmacokinetics of ABT-263 when combined with dose-intense rituximab in previously untreated patients with B-cell CLL.

Progression-free survival [ Time Frame: From randomization to the first occurrence of progression, relapse, or death on study (approximately 40 months from First Patient In [FPI]) ] [ Designated as safety issue: No ]

Progression-free survival as assessed by a blinded, independent review [ Time Frame: From randomization to the first occurrence of progression, relapse, or death on study (approximately 40 months from FPI) ] [ Designated as safety issue: No ]

ORR as assessed by a blinded, independent review [ Time Frame: Approximately 40 months from FPI ] [ Designated as safety issue: No ]

Duration of response as assessed by a blinded, independent review [ Time Frame: Approximately 40 months from FPI ] [ Designated as safety issue: No ]

CR rate as assessed by a blinded, independent review [ Time Frame: Approximately 40 months from FPI ] [ Designated as safety issue: No ]

Overall survival (OS) [ Time Frame: From randomization until death due to any cause (approximately 4 years after Last Patient In) ] [ Designated as safety issue: No ]

Prior radiotherapy to a lesion(s) that will be used to assess response unless that lesion(s) shows clear evidence of progression at baseline

Patients with a history of other malignancies within 2 years prior to study entry except for adequately treated carcinoma in situ of the cervix, basal or squamous cell skin carcinoma, low-grade, localized prostate cancer treated surgically with curative intent or one that carries a good prognosis, in situ ductal carcinoma of the breast treated with lumpectomy alone with curative intent

Prior treatment with rituximab, ABT-263 or other pro-apoptotic agents

Current or recent (within the 28 days prior to initiation of study treatment) participation in another experimental drug study

Major surgical procedure (excluding lymph node biopsy) or significant traumatic injury within 28 days prior to treatment onset or anticipation of the need for major surgery during the course of the study

Active infection requiring parenteral antibiotics or antiviral or antifungal agents at the onset of study treatment

Receipt of primary or booster vaccination with live-virus vaccines for up to 6 months prior to initiation of study treatment

Patients receiving therapeutic anticoagulation with heparin or warfarin or patients receiving any drugs or herbal supplements that are known to inhibit platelet function (including low-dose aspirin) within 7 days of the first dose of ABT-263. Note: Patients receiving low-dose anticoagulation for the purpose of maintaining central venous catheter patency are eligible.

Patients who have an inherited or acquired bleeding diathesis, including (but not limited to) hemophilia or immune or thrombotic thrombocytopenic purpura, or who have had an underlying condition that predisposes to abnormal bleeding (e.g., peptic ulcer disease) within 1 year prior to the first dose of ABT-263

Concurrent (or within 7 days prior to the first dose of study treatment) systemic corticosteroid therapy except some low-dose corticosteroid therapies

History of other disease, metabolic dysfunction, physical or laboratory finding(s) giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug, might affect interpretation of the results of the study or render the patient at high risk from treatment complications

History of anaphylaxis, allergic reaction, or hypersensitivity to sulfites (sodium metabisulphite is included in study drug formulation)

Any contraindication to alcohol ingestion (study drug formulation includes approximately 15% ethanol)

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01087151